Saturday, March 20, 2010

Tomorrow's Washington Post will run a slightly updated version of an award-winning story on the ways in which some executives -- even the very largest pharmaceutical behemoths on the planet -- still commit fraud. They do it by minimizing risks of side-effects, and pushing doctors to use a drug for unapproved purposes -- all to amp sales. If only required to pay out, say 10 percent of the amount they rake in -- in criminal and civil fines. . . they will keep doing it.

. . . .Pfizer bought Pharmacia & Upjohn in April 2003. From 2001 through 2003, P&U, first as an independent company and then as a unit of Pfizer, paid doctors more than $5 million in cash to lure them to resorts, where salespeople illegally pitched off-label uses for Bextra, P&U admitted.

In her guilty plea, Holloway said her team had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn't mention the increased risk of heart attacks in their marketing. They told doctors that side effects were no worse than those of a sugar pill, Holloway said.

In 2003, Holloway reported her unit's off-label promotions of Bextra up the corporate ladder at Pfizer, according to a presentencing memo to the judge written by Robert Ullmann, Holloway's attorney. Top managers didn't attempt to halt the illegal conduct, the memo said. . . .

On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra -- a drug approved only for the relief of arthritis and menstrual discomfort -- for treatment of acute pain of all kinds.

For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the United States and 49 states.

"At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004, Pfizer was itself in its other operations violating those very same laws," Loucks, 54, says. "They've repeatedly marketed drugs for things they knew they couldn't demonstrate efficacy for. That's clearly criminal."

The penalties Pfizer paid for promoting Bextra off-label were the latest chapter in the drug's benighted history. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005. . . .

Indeed. This is another powerful reason to get behind the reform bill. [Here is the earlier piece I wrote on Mr. Loucks' appeal to pass health care reform -- and to continue funding of the US Attorneys' taskforces on health care fraud.] A sincere Hat Tip to Jack (the "Insider") Friday -- at PharmaGossip.

Senator Grassley's Concern

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FDA Drug Facts

CEO Fred Hassan

The Condor. . . .

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